QC Systems Specialist - Singapore - Coalesce Management Consulting

    Coalesce Management Consulting
    Coalesce Management Consulting Singapore

    10 hours ago

    Pharmaceutical / Bio-tech
    Description

    Responsibilities:

    • Serve as representative for QC system owners, supporting operational and compliance activities.
    • Review and approve validation lifecycle documentation.
    • Oversee commissioning, qualification, decommissioning, and related documentation, including exception handling and closure.
    • Provide guidance on equipment/system qualification and decommissioning activities.
    • Support change control assessments and reviews.
    • Conduct data integrity assessments and ensure compliance with internal and regulatory standards.
    • Offer input and direction on qualification and decommissioning activities where applicable.

    Requirements:

    • Prior experience in biotech or pharmaceutical operations is preferred.
    • Strong knowledge of validation approaches, strategies, and philosophies.
    • Familiarity with laboratory instruments, computerized system validation, and qualification of controlled temperature chambers.
    • Experience with electronic validation tools (e.g., KNEAT) is advantageous.
    • Solid understanding of change control methodology, GMP, GDP, and data integrity principles.
    • Strong interpersonal and communication skills, with the ability to collaborate across teams and vendors.
    • Team‑oriented mindset with focus on safety, quality, and timelines.
    • Ability to work independently with minimal supervision.

    What we offer

    At Coalesce Management Consulting Pte. Limited, we are committed to providing our employees with a supportive and rewarding work environment. We offer competitive remuneration, opportunities for career growth and development, and a range of benefits to support your wellbeing. Join our dynamic team and contribute to the success of our clients' projects.


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